Intensive Cryotherapy in the Emergency Department for Acute Musculoskeletal Injuries
1 other identifier
interventional
38
0 countries
N/A
Brief Summary
Acute musculoskeletal (MSK) injuries, including strains, sprains or contusions, are a common reason patients seek emergency care. Pain control is an essential component of treatment. Within the orthopedic literature, there is robust body of research supporting the use of cryotherapy for post-operative patients and injured athletes. However, within the emergency department (ED), studies have been focused on pharmacologic analgesia. The absence of evidence on optimal method or impact of ice therapy for acute MSK injuries contributes to inconsistent practice patterns that may impede symptom control or increase narcotic usage. The specific aim of the ICED investigation is to evaluate the effectiveness of intensive cryotherapy for the treatment of pain due to acute MSK injuries treated in the ED. Secondary outcomes include length-of-stay (LOS), patient satisfaction, and narcotic usage.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable pain
Started Feb 2016
Longer than P75 for not_applicable pain
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2016
CompletedFirst Submitted
Initial submission to the registry
March 10, 2016
CompletedFirst Posted
Study publicly available on registry
March 25, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2019
CompletedNovember 6, 2019
November 1, 2019
1.1 years
March 10, 2016
November 3, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
Change in pain level
20 minutes
Change in pain level
60 minutes
Secondary Outcomes (1)
Change in analgesic utilization
24hr
Study Arms (2)
Intensive cryotherapy
EXPERIMENTALApplication of ice in a plastic bag wrapped to the patient's site of pain, and kept in place for 20min.
Control
NO INTERVENTIONExisting pain control practice of physicians and nurses, which includes application of a chemical cold pack.
Interventions
Application of ice inside a plastic bag wrapped to the patient's site of pain, and held in place for 20min.
Eligibility Criteria
You may qualify if:
- all people presenting to the ED with musculoskeletal injuries
You may not qualify if:
- Patients with hip fractures
- Patients with open fractures
- Patients with altered mental status who are unable to consent to participate in the study
- Patients activated as a trauma
- Patients with fractures or dislocations requiring closed reduction in the emergency department
- Minors
- Prisoners
- Patients with known pregnancy
- Patient who are receiving investigational drug as part of another study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief Resident
Study Record Dates
First Submitted
March 10, 2016
First Posted
March 25, 2016
Study Start
February 1, 2016
Primary Completion
February 28, 2017
Study Completion
October 30, 2019
Last Updated
November 6, 2019
Record last verified: 2019-11
Data Sharing
- IPD Sharing
- Will not share